This invention relates to collapsible/expandable prosthetic heart valve delivery systems which can house, retain, maintain, transport, deploy, help anchor, and release (and, if necessary, reposition and/or retrieve) a collapsible prosthetic heart valve via a minimally invasive (or at least reduced invasiveness) port access, e.g., at the apex of a patient's heart and through the intercostal space of the patient's ribs.
The field of collapsible/expandable prosthetic heart valves is relatively new. The general idea is to provide a prosthetic heart valve that can be collapsed to a relatively small size (diameter) for delivery into the patient with reduced invasiveness to the patient's body (typically via a tube of relatively small diameter). When the valve reaches the desired implant site in the patient, the valve is released from the delivery apparatus and expanded to its full operating size. This also includes securing the valve to tissue of the patient at the implant site.
There are several approaches to delivering and deploying such collapsible/expandable prosthetic heart valves using arterial or venous systems of the patient. However, these approaches may impose certain constraints, such as requiring smaller delivery system profiles (cross sections) so that they can be used in diseased and smaller vessels and to minimize emboli risk. This may result in undesirable trade-offs in valve design and performance in order to accommodate the demand for delivery of the valve through smaller delivery system profiles.
Ideally, the delivery system should be designed around a durable and efficient valve design, thus not compromising any of the valve's long-term implant performance requirements. In doing so, the valve design should be adequate for its intended performance and long-term durability functions. This may result in valve profiles in the collapsed state that are somewhat larger than would be appropriate for human artery or vein delivery approaches, thereby calling for an alternative route to delivering the valve to its intended implant site.
The transseptal (through the septum of the heart) antegrade (delivery in the same direction as native blood flow) approach is one approach that has been tried. In the transseptal approach, access is gained through the venous circulatory system leading to the right atrium. A puncture is made through the septum wall separating the left and right atria (hence the term transseptal). The catheter is then advanced through the mitral valve into the left ventricle and looped back up ending at the aortic valve. This approach may have some disadvantages, however. For example, it may result in damage to the mitral valve and the associated chordae when trying to gain access to the aortic valve. In contrast, the transapical (through the apex of the heart) antegrade approach may offer a better and safer alternative for entering the left ventricle (“LV”) for direct access to the aortic and mitral valves. (See, for example, P. Tozzi et al., “Endoscopic off-pump aortic valve replacement: does the pericardial cuff improve the sutureless closure of left ventricular access?”, European Journal of Cardio-thoracic Surgery 31 (2007) 22-25, available online 6 Sep. 2006.) Accessing the LV through a small port at the apex (lower end) of the heart is not new, as this has been the practice for several decades in placing bypass shunts in pediatrics. There are good, long-term, clinical experiences with this access approach to render it safe and effective. With an optimum delivery system design, safer and more effective direct access to the aortic or mitral valve can be achieved for the purposes of repair and/or replacement of defective native valves.